Creon has no or negligible influence on the ability to drive or use machines.
Section 4.8: Undesirable effects
From:
In pooled data from clinical trials, the overall incidence of adverse drug events reported with Creon was the same as with placebo. The incidence tended to reflect the general symptomatology of the underlying disease.
Very common (Frequency >10%):
Gastrointestinal disorders: abdominal pain
Common (Frequency 1-10%):
Gastrointestinal disorders: diarrhoea, constipation, abnormal stool, nausea and vomiting.
Skin and subcutaneous tissue: allergic or hypersensitivity reactions.
Stricture of the ileo-caecum and large bowel an colitis has been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. To date, Creon 10000 and 25000 have not been implicated in the development of colonic damage. Experience with Creon 40000 and Creon Micro in clinical use is limited. Unusual abdominal symptoms or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage especially if the patient is taking in excess of 10,000 units lipase/kg/day.
To:
In clinical trials, more than 600 patients with pancreatic exocrine insufficiency, due to cystic fibrosis, chronic pancreatitis, and pancreatic surgery were exposed to Creon. The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity.
The following adverse reactions have been observed during placebo-controlled clinical trials with the below indicated frequencies
Gastrointestinal disorders
Common (≥1/100, <1/10): nausea, vomiting, constipation, diarrhoea and abdominal distension
Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for abdominal pain (very common, ≥1/10).
Skin and subcutaneous tissue disorders
Uncommon(≥1/1,000, ≤1/100): rash
Pruritus and urticaria have been additionally identified as adverse reactions during post-approval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.
Multiple clinical trials were conducted in other patient populations: HIV, acute pancreatitis, diabetes mellitus. No additional adverse drug reactions were identified compared to the above three patient groups.
Paediatric population
No specific adverse reactions were identified in the paediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.
Section 4.9: Overdose
From:
Most cases respond to supportive measures including stopping enzyme therapy, ensuring adequate rehydration. Rarely cases of hyperuricosuria and hyperuricaemia have been reported with very high doses of pancreatin.
To:
Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia.
Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are recommended.